Data / Medical devices / Orthodontic Software / China
FDA-registered makers of Orthodontic Software in China: 5 establishments
5 establishments in China are registered with the FDA to make Orthodontic Software (product code PNN). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Orthodontic Software
- Product code
- PNN
- Country
- China
Makers of Orthodontic Software in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hangzhou Chohotech Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | May 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Ea Medical Instruments Co., Ltd. | Yangpu District Shanghai, China | Manufacturer | 1 | June 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Envista (Sichuan) Medical Device Co., Ltd. | Ziyang Sichuan, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.